Joint, Temporomandibular, Implant
FDA adverse event reports and recall history for joint, temporomandibular, implant (product code LZD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,076
- Deaths
- 7
- Injuries
- 2,749
- Malfunctions
- 190
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-22Open, ClassifiedProcess control
TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
- 2025-11-14Open, ClassifiedProcess control
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
- 2024-09-26Open, ClassifiedMixed-up of materials/components
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- 2023-03-08Open, ClassifiedNo Marketing Application
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Device was shipped without having regulatory approval.
- 2018-04-19TerminatedError in labeling
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
This device was mislabeled and is not the correct component for this patient.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
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